Drug Delivery Safety System

ABSTRACT

A drug delivery safety system includes a programmer with a display and a communications device adapted to communicate with an ambulatory medical device. The programmer has access to a database of information, and is adapted to receive and process the information and a user input and to control the display to provide a graphical user interface that prompts a user of the programmer to provide an additional user input when the user input requests a drug delivery protocol for the ambulatory medical device that is not already stored in the database as a clinician-approved drug delivery protocol.

BACKGROUND OF THE INVENTIONS

1. Field of Inventions

The present inventions relate generally to systems for delivering drugsto ambulatory medical devices such as implantable drug pumps (IDPs).

2. Description of the Related Art

Known implantable drug pumps can be used to deliver several differenttypes of drugs (e.g., to treat various types of pain and spasticity),with rates of delivery and units of these rates that often vary widely.Implantable drug pumps, especially for intrathecal delivery, can be usedto deliver a diverse array of drugs of differing concentrations, whichmakes it difficult to put bounds on the allowable delivery rates. Forexample, because any one of a number of drugs of various concentrationscan be used, it is problematic to limit the overall rate of the pump.

It would be helpful to be able to provide a drug delivery safety systemthat allows a programmer to put bounds on the allowable delivery ratesfor each drug. It would also be useful to be able to provide a drugdelivery safety system that allows a programmer of an implantable drugpump to check a specified delivery rate to verify that it is within asafe limit. Additionally, it would be helpful to be able to providesafety features to implantable medical device programmers in order tolimit the possibility that a clinician would program a harmful oruncomfortable therapeutic regimen.

SUMMARY OF THE INVENTIONS

In an example embodiment, a drug delivery safety system includes aprogrammer with a display and a communications device adapted tocommunicate with an ambulatory medical device. The programmer has accessto a database of information, and is adapted to receive and process theinformation and a user input and to control the display to provide agraphical user interface that prompts a user of the programmer toprovide an additional user input when the user input requests a drugdelivery protocol for the ambulatory medical device that is not alreadystored in the database as a clinician-approved drug delivery protocol.

In an example embodiment, a drug delivery safety system includes aprogrammer with a display and a communications device adapted tocommunicate with an implantable drug pump. The programmer has access toa database of therapeutic limits information relating to the implantabledrug pump, and is adapted to receive and process the therapeutic limitsinformation and a user input relating to a requested change to a drugdelivery protocol currently associated with the implantable drug pump,and to control the display to provide an indication of an estimated datein which the implantable drug pump will experience a low reservoircondition.

The above described and many other features of the present inventionswill become apparent as the inventions become better understood byreference to the following detailed description when considered inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Detailed descriptions of exemplary embodiments will be made withreference to the accompanying drawings.

FIG. 1 illustrates an implantable medical device and exampleprogrammers/controllers, which embody the drug delivery safety systemsdescribed herein.

FIG. 2 is a plan view of a programmer in accordance with one embodimentof the present invention, shown establishing a communications link withan implantable medical device.

FIG. 3 is a block diagram of the programmer and implantable medicaldevice of FIG. 2.

FIG. 4 is a plan view of a programmer in accordance with anotherembodiment of the present invention.

FIG. 5 is a plan view of a programmer in accordance with still anotherembodiment of the present invention.

FIG. 6 is a flow chart in accordance with one embodiment of the presentinvention.

FIG. 7 is a flow chart in accordance with another embodiment of thepresent invention.

FIG. 8 is a flow chart in accordance with an embodiment of the presentinvention where a user changes a therapy parameter for an implantablemedical device.

FIG. 9 is a flow chart in accordance with an embodiment of the presentinvention where a user changes the concentration of a drug in a pump.

FIG. 10 is a flow chart in accordance with an embodiment of the presentinvention where a user changes the delivery rate of an implantable drugpump.

FIG. 11 shows a graphical user interface generated (displaying dosageand refill user interfaces) generated by a pump programmer according toan example embodiment of the present invention.

FIG. 12 shows a graphical user interface (displaying a clinic formulary)generated by a pump programmer according to an example embodiment of thepresent invention.

FIG. 13 shows a graphical user interface (indicating that a daily orprimary dosage has increased by a threshold percentage) generated by apump programmer according to an example embodiment of the presentinvention.

FIG. 14 shows a graphical user interface (indicating that a daily orprimary dosage has decreased by a threshold percentage) generated by apump programmer according to an example embodiment of the presentinvention.

FIG. 15 shows a graphical user interface generated (indicating that, inan attempt to enable a Patient Controlled Analgesia (PCA) dosage, themedication has been defined not to be suitable for PCA in the ClinicalFormulary) by a pump programmer according to an example embodiment ofthe present invention.

FIG. 16 shows a graphical user interface (indicating that a PCA dosagehas increased by a threshold percentage) generated by a pump programmeraccording to an example embodiment of the present invention.

FIG. 17 shows a graphical user interface (indicating that a PCA dosagehas decreased by a threshold percentage) generated by a pump programmeraccording to an example embodiment of the present invention.

FIG. 18 shows a graphical user interface (displaying a calculation of anempty reservoir date in response to a daily dosage change) generated bya pump programmer according to an example embodiment of the presentinvention.

FIG. 19 shows a graphical user interface (presenting a writeconfirmation display) generated by a pump programmer according to anexample embodiment of the present invention.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The following is a detailed description of the best presently knownmodes of carrying out the inventions. This description is not to betaken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of the inventions.

The present remote controls or programmers have application in a widevariety of medical device systems. One example of such a system is animplantable infusion device system and the present inventions arediscussed in the context of implantable infusion device systems. Thepresent inventions are not, however, limited to implantable infusiondevice systems and are instead also applicable to other medical devicesystems that currently exist, or are yet to be developed. For example,the present inventions are applicable to other ambulatory medical devicesystems. Such systems include, but are not limited to, externallycarried infusion pump systems, implantable pacemaker and/ordefibrillator systems, implantable neural stimulator systems, andimplantable and/or externally carried physiologic sensor systems.

One example of a programmer in accordance with the present inventions isan implantable infusion device system. The implantable infusion devicesystem may include any one of the remote controls or programmersdescribed herein in combination with an implantable infusion device.FIG. 1 illustrates an implantable medical device 300 and exampleprogrammers/controllers, which embody the drug delivery safety systemsdescribed herein. The example programmers/controllers includes aprogrammer 100 a (such as a portable computing device (PCD) or personaldigital assistant (PDA)) and a clinician programmer 100 b (such as aclinician programmer/field support system). In this example, theprogrammer 100 a includes a communication device which facilitates radiofrequency (RF) communications with the implantable medical device 300 sothat RF telemetry can be communicated between the devices. Also in thisexample, the clinician programmer 100 b is connected to a programmerinterface module 101 with a USB Interface; the programmer interfacemodule 101, in turn, facilitates RF communications between the clinicianprogrammer 100 b and the implantable medical device 300. It should beunderstood that other types of programmers/controllers as well as othercommunications interfaces can also be employed.

Referring to FIG. 2, in an example embodiment, an implantable medicaldevice system 10 includes a programmer 100 a and an implantable medicaldevice 300. In an example embodiment, the programmer 100 a includes abattery or other power source 136, a controller 138, such as amicroprocessor, microcontroller or other control circuitry, memory 139,a user input mechanism 142 (such as a keyboard, mouse, touch screenand/or voice recognition device), one or more LEDs 146 (and/or alarm147), and a display 148. The memory 139 can also be contained within thecontroller 138 (e.g., within a microcontroller). By way of example andnot of limitation, the alarm 147 can include one or more of an audiospeaker and a vibration device. A communication device 140 (including anantenna if necessary) is also provided. In an example embodiment, thedisplay 148 is a touch screen configured to receive user inputs, i.e.,at least a portion of the functionality of the user input mechanism 142is provided by the display 148.

The communication device 140 establishes a communications link 141(e.g., an RF communications link) with the implantable medical device300. Although the present inventions are not limited to any particularcommunication device, in an example embodiment, the communication device140 is a telemetry device that transmits an RF signal at a specifiedfrequency or set of frequencies. The RF signal may, in some instances,be a carrier signal that carries bit streams. The communication device140 is also configured to receive signals from the implantable medicaldevice 300. Other exemplary communication devices include oscillatingmagnetic field communication devices, static magnetic fieldcommunication devices, optical communication devices, ultrasoundcommunication devices and direct electrical communication devices.

In this example embodiment, the implantable medical device 300 is animplantable infusion device and includes a medication reservoir 302 anda pump or other fluid transfer device 304 within a housing 306. The pump304 transfers medication from the reservoir 302 through a catheter 308to the target region within the body. Operation of the implantablemedical device 300 is controlled by a controller 310, such as amicroprocessor, microcontroller or other control circuitry, inaccordance with instructions stored in memory 312. Power is provided bya battery or other power source 314. An alarm 316 (e.g., an audiblealarm such as an audio speaker, and/or a vibration device) may also beprovided in order to inform the patient, for example, when the amount ofmedication in the reservoir 302 is low or when the amount of energystored in the battery 314 is low. A refill port 318, which allows thereservoir to be refilled while the implantable medical device 300 iswithin the patient, is positioned on the exterior of the housing 306.

A communication device 320 is also provided. In this example embodiment,the communication device 320 is configured to receive signals from, andtransmit signals to, the programmer 100 a. In an example embodiment, thecommunication device 320 is a telemetry device that transmits andreceives RF signals at a specified frequency or set of frequencies. TheRF (or other) signal may, in some instances, be a carrier signal thatcarries bit streams.

It should be noted here that, in the context of the present inventions,different types and/or combinations of user input devices can beemployed with any given programmer/controller device. As illustrated forexample in FIG. 4, the exemplary programmer 100 c includes a housing 102c and a touch screen 228. A controller and a communication device (notshown) are also provided. The touch screen 228 may be used to displayone or more button configurations in order to allow the user toaccomplish various tasks. At least one of the displayed buttons is abolus delivery button 104 c. The housing 102 c may also be provided withone or more button control elements 106 c (e.g. buttons), which areoperably connected to the controller, and a power on/off button 230.

One or more button control elements may, alternatively, be provided on atouch screen. Turning to FIG. 5, the exemplary programmer 100 d includesa housing 102 d, a touch screen 228 that may be used to, among otherthings, display a bolus delivery button 104 d and a pair of buttoncontrol elements 106 d, and a power on/off button 230.

Referring again to FIG. 3, in this example embodiment, the controller138 and memory 139 are contained within the housing 102 of theprogrammer 100 a. The scope of the present invention also includesprogrammers or programming systems where the functionality of thecontroller 138, or a portion of this functionality, is “migrated” to aphysical location that is external to the housing 102. Similarly, someor all of the memory 139 can be physically located external to thehousing 102. Such external controller(s) and memory device(s) can beoperatively interfaced with the programmer 100 a with wireless or wiredcommunication links.

In an example embodiment, a database of information relating to theimplantable medical device 300 (e.g., an implantable drug pump) isstored in the memory 139. In an example embodiment, the informationincludes a list of clinician-approved drugs and dosage parameters suchas rate, concentration, total daily dose, therapeutic limits, etc.associated with each of the drugs. In an example embodiment, a baselinedatabase of information is initially uploaded into the memory 139. In anexample embodiment, the controller 138 manages the function of uploadinga database of information, as well as writing changes, additions orupdates to the database of information. Under control of the controller138 and in response to user inputs provided via the user input mechanism142, the programmer 100 a performs the various functions describedherein, in particular, providing an interactive user interface, e.g., agraphical user interface (GUI), at the display 148.

Referring to FIG. 6, in an example embodiment, a method 600 ofcontrolling a drug delivery safety system is now described. At 602,ambulatory medical device (e.g., IDP) information and programmer userinput(s) are received and processed by the controller 138. For example,a drug delivery protocol requested by a user of the programmer 100 a isevaluated in relation to clinician-approved drug delivery protocolsstored in database of information. At 604, it is determine whether arequested drug delivery protocol is clinician-approved. If the result ofthis determination is affirmative, the user of the programmer 100 a, at606, is prompted to provide an additional input or verification of therequested drug delivery protocol. At 608, the user is prompted toprovide verification as to whether the database of information for theambulatory medical device is to be updated. However, if the requesteddrug delivery protocol is not clinician-approved (vis-a-vis the databaseof information), at 610, the programmer 100 a generates a warningindicating this. By way of example, the warning can be generated usingone or more of the LED(s) 146, alarm 147, and display 148. At 612, therequested drug delivery protocol is limited or denied.

In example embodiments of drug delivery safety systems, the programmer100 a tracks a standard maximum dosage used for each drug that aclinician specifies on the programmer. If at any time, the clinicianspecifies a dosage that is greater than the standard maximum dosage, theprogrammer 100 a alerts the clinician of the abnormally high rate. Theprogrammer 100 a then generates a user prompt, e.g., at the display 148,asking the clinician if this is an acceptable rate. If the clinicianspecifies “yes”, then the programmer generates a prompt asking theclinician if this rate should be saved as the new standard maximumdosage. If the clinician specifies “yes”, then the programmer 100 asaves this rate in its database of standard maximum dosages and willassociate this rate with the specified drug.

Example embodiments of drug delivery safety systems allow the user toedit or reset the rates for all (or some) of the drugs in its database.Referring to FIG. 11, in an example embodiment, a graphical userinterface 1100 is generated at the display 148. In this exampleembodiment, the graphical user interface 1100, denoted “Pump: dosage andrefill”, includes a Base Dose display area 1102, which displays a tableof information for Base Dose medications. More specifically, in thisexample embodiment, Base Dose display area 1102 shows a table ofinformation organized under the headings: Medication, Concentration, andTotal Daily Dose. In this example embodiment, the graphical userinterface 1100 also includes a Daily Profile display area 1104 in whicha daily profile for one or more drugs is shown, with drug(s)concentration plotted over time. This graphical presentation of thedaily profile provides the clinician or other user of the programmer 100a with tool for assessing possible adjustments to the daily profile.

In an example embodiment, the programmer 100 a is configured to generatethe graphical user interface 1100 such that the Total Daily Dose (foreach Medication) shown in the Base Dose display area 1102 can beadjusted by entering new dosages. In another example embodiment, theplot generated in the Daily Profile display area 1104 is automaticallyadjusted depending upon the dosages entered into the fields in the TotalDaily Dose column. In an example embodiment, an edit button 1106 in theDaily Profile display area 1104, when actuated, permits a user to editthe daily profile. In another example embodiment, the Total Daily Dosevalue for each Medication is automatically adjusted depending uponchanges made to the daily profile.

In this example embodiment, the graphical user interface 1100 alsoincludes a Read Pump button 1108, a Write Pump button 1110, and a StopPump button 1112, which initiate these respective functions whenactuated.

In an example embodiment, FIG. 12 shows a graphical user interface 1200(displaying a Clinic Formulary table 1202) generated by the programmer100 a. In this example embodiment, the Clinic Formulary table 1202 showseach Medication, e.g., previously used, clinician-approved medications,in the database of information. In an example embodiment, the ClinicFormulary includes a therapy and drug database. In this exampleembodiment, for each Medication which is part of a dosage protocol, theClinic Formulary table 1202 indicates: Display Units, Max. Base Rate,Rate Units, Max. Daily Dose, Dosage Units, Max. Concentration,Concentration Units, and PCA Med. information.

In an example embodiment, the programmer 100 a keeps track of all drugsthat the clinician has used in the past. When the clinician wishes torefill a pump with a new drug or drug mixture, he or she is providedwith a list of all previously-used drugs and with an option touse/specify a drug that is not on this list. In an example embodiment,the add button 1204 causes the programmer 100 a to generate a userinterface which facilitates this function.

In an example embodiment, when a new drug is to be specified, theprogrammer 100 a allows the clinician to type in the name of this newdrug. This name is (at least temporarily) saved in a database or list ofdrugs. In an example embodiment, the name of the new drug then appearsin the list of drugs that are in the drug mixture with which the pumphas been or is about to be refilled. At this point, in an exampleembodiment, no delivery rate or rate units are displayed for the newdrug. In an example embodiment, the user is then prompted to enter thisinformation. After having entered this information, in an exampleembodiment, the programmer 100 a generates a prompt asking the clinicianif this rate and units should be saved in the drug database as the newmaximum rate and default display units for the specified drug. When thisdrug is selected to be added for any patient's pump, in an exampleembodiment, the programmer 100 a notifies the clinician or other user ifthe rate is above the maximum rate in the database.

Example embodiments of drug delivery safety systems provide confirmationdialogs for unexpectedly high (or low) rates. This protects against dataentry errors by the clinician or other user.

FIG. 13 shows a graphical user interface 1300, with a “pop-up” window1302 indicating that a daily or primary dosage has increased by athreshold percentage (in this example, by 20%). In this exampleembodiment, the “pop-up” window 1302 includes fields 1304 and 1306which, when actuated (e.g., by positioning a cursor over the field andclicking a mouse), confirm or cancel a user's request for a particulardosage, respectively. Similarly, FIG. 14 shows a graphical userinterface 1400, with a “pop-up” window 1402 indicating that a daily orprimary dosage has decreased by a threshold percentage (in this example,by 20%). In this example embodiment, the “pop-up” window 1402 includesfields 1404 and 1406 which, when actuated (e.g., by positioning a cursorover the field and clicking a mouse), confirm or cancel a user's requestfor a particular dosage, respectively.

Example embodiments of drug delivery safety systems provide confirmationdialogs relating to requested PCA dosages. In an example embodiment,users are not allowed to enable PCA when at least one of the medicationsin the IDP's admixture has been defined not to be suitable for PCA inthe Clinical Formulary. In an example embodiment, users cannot configurea PCA Bolus rate which exceeds a threshold rate, for example, 30μL/minute (thirty microliters).

FIG. 15 shows a graphical user interface 1500, with a “pop-up” window1502 indicating that, in an attempt to enable a PCA dosage, themedication has been defined not to be suitable for PCA in the ClinicalFormulary. In this example embodiment, the “pop-up” window 1502 includesa field 1504 which, when actuated (e.g., by positioning a cursor overthe field and clicking a mouse), verifies that PCA is allowed for therequested medication.

FIG. 16 shows a graphical user interface 1600, with a “pop-up” window1602 indicating that a PCA dosage is not less than an allowed thresholdpercentage (in this example, 20% of the Base Dose). In this exampleembodiment, the “pop-up” window 1602 includes fields 1604 and 1606which, when actuated (e.g., by positioning a cursor over the field andclicking a mouse), confirm or cancel a user's request for a particularPCA dosage, respectively. Similarly, FIG. 17 shows a graphical userinterface 1700, with a “pop-up” window 1702 indicating that a PCA dosagehas decreased by a threshold percentage (in this example, by 20%). Inthis example embodiment, the “pop-up” window 1702 includes fields 1704and 1706 which, when actuated (e.g., by positioning a cursor over thefield and clicking a mouse), confirm or cancel a user's request for aparticular PCA dosage, respectively.

Example embodiments of drug delivery safety systems provide confirmationdialogs relating to the writing of data to the ambulatory medical device(e.g., IDP). In an example embodiment, when the user requests queueddata to be written to the IDP, the programmer generates a confirmationwindow which displays the data that is to be written to the IDP.

FIG. 19 shows a graphical user interface 1900, with a Write ConfirmationDisplay window 1902 indicating both the previous and new programmingvalues/information. In an example embodiment, all programming changesare highlighted (e.g., presented bold and/or in a different color). Inan example embodiment, the Write Confirmation Display window 1902reminds the user that a daily profile has not been configured, when thisis the case (in this example, by displaying the text: “Pump NotProgrammed”). In this example embodiment, the graphical user interface1900 includes fields 1904 and 1906 which, when actuated (e.g., bypositioning a cursor over the field and clicking a mouse), confirm orcancel a user's request to write new programming data, respectively.

Example embodiments of drug delivery safety systems are configured totrack clinician-specified therapeutic parameters and to display warningswhen abnormal parameters are specified. In an example embodiment, aprogrammer is configured (e.g., programmed) to track the drugs used fora particular disease type or disease state and uses this information towarn the clinician when an abnormal therapy is selected to treat aparticular disease type or state. For an implantable drug pump, by wayof example, the programmer displays a warning if a drug is used to treata new disease type. For example, if Morphine Sulfate has only been usedto treat nociceptive pain and Baclofen has only been used to treatspasticity, the programmer displays a warning if Morphine Sulfate isused to treat a patient with spasticity.

Example embodiments of drug delivery safety systems are configured togenerate warnings or limitations for any therapeutic parameters byeither tracking usage per clinic or per patient. For example, it ispossible for a drug pump programmer to limit the medication deliveryrate in response to the maximum rate previously used for the specifieddrug either within the clinic as a whole or for the specific patientbeing treated. Limiting or warning when clinic maximums for specifieddrugs are exceeded is appropriate, because drugs usually haveside-effects that present themselves at dosages that are specific todrug type. Different patients can have different tolerances to anyselected drug; therefore, displaying a warning based upon apatient-specific maximum rate for a drug is appropriate in someinstances.

Example embodiments of drug delivery safety systems are configured tolimit user input based upon therapy type. In an example embodiment, adrug delivery safety system is configured to update the acceptancelimits for the critical therapy parameters by monitoring the clinicianinput.

Referring to FIG. 8, in an example embodiment, a method 800 ofcontrolling a drug delivery safety system, in response to user changesto a therapy parameter for an implantable medical device, is nowdescribed. At 802, a user adds/selects a new therapy, which is not inthe therapy database, to the implantable medical device. At 804, theuser is prompted for the therapy name and parameter(s). A determinationis made, at 806, as to whether the therapy name is in the database. Ifyes, at 808, a message is displayed, such as: “Therapy is already indatabase.” If no, at 810, the therapy is added to the database with allunspecified parameters denoted as “undefined”. At 812, the new therapyis added to the therapy database and to the implantable deviceprogramming.

At 822, a user changes a therapy parameter for the implantable medicaldevice. A determination is made, at 824, as to whether the parameter isoutside the limits in the database for this therapy. If no, there is noneed to adjust parameter limits in the database and, at 832, theparameter display is updated. If yes, at 826, the user is prompted toindicate whether the value of this parameter should be used to expandthe limits in the therapy database. At 828, the user answer to thisprompt is processed. If the user answer is “Yes”, at 830, the parametervalue is used to expand the parameter limits in the therapy database. Ifthe user answer is “No”, at 834, the user is notified that the specifiedparameter is outside of the therapy database limits. Additionally, theuser is asked to verify again that the specified parameter should beused. At 836, the user answer to this prompt is processed. If the useranswer is “Yes”, at 832, the parameter display is updated. If the useranswer is “No”, at 838, the parameter display is cleared or reset.

Example embodiments of drug delivery safety systems are configured tolimit the concentration for specified drug(s) for an ambulatory medicaldevice (e.g., an implantable pump system).

Referring to FIG. 9, in an example embodiment, a method 900 ofcontrolling a drug delivery safety system, in response to user changesto the concentration of a drug in a pump, is now described. At 902, auser adds a “New Drug” that is not in the drug database to the pump. At904, the user is prompted for the drug name. A determination is made, at906, as to whether the drug name is in the database. If yes, at 908, amessage is displayed, such as: “Drug is already in database.” If no, at910, the drug is added to the database with undefined units and 0 formaximum concentration. At 912, the new drug appears in the lists forboth the reservoir contents and available medications.

At 922, a user changes the concentration of a drug in the pump. Adetermination is made, at 924, as to whether the concentration isgreater than the maximum concentration for this drug in the database. Ifno, there is no need to adjust the maximum concentration in the databaseand, at 932, the new concentration is displayed. If yes, at 926, theuser is prompted to indicate whether this concentration should be usedas the maximum concentration for this drug. At 928, the user answer tothis prompt is processed. If the user answer is “Yes”, at 930, thespecified concentration is saved as the maximum concentration for thespecified drug in the database. If the user answer is “No”, at 934, theuser is notified that the specified concentration is greater than thedrug database maximum. Additionally, the user is asked to verify againthat the specified concentration should be used. At 936, the user answerto this prompt is processed. If the user answer is “Yes”, at 932, thenew concentration is displayed. If the user answer is “No”, at 938, theconcentration field is cleared.

Example embodiments of drug delivery safety systems are configured tolimit the programmed drug rate for an ambulatory medical device (e.g.,an implantable pump system).

Referring to FIG. 10, in an example embodiment, a method 1000 ofcontrolling a drug delivery safety system, in response to user changesto the delivery rate of an implantable drug pump, is now described. At1022, a user changes the delivery rate for the implantable drug pump. Adetermination is made, at 1024, as to whether the rate is greater thanthe maximum rate in the database for any of the programmed drugs. If no,there is no need to adjust the maximum rate for each drug in thedatabase and, at 1032, the new rate is displayed. If yes, at 1026, theuser is prompted to indicate whether this rate should be used as themaximum rate in the database for each of the drugs in the pump for whichthe maximum rate was violated. At 1028, the user answer to this promptis processed. If the user answer is “Yes”, at 1030, the specified rateis saved as the maximum rate for each drug in the database for which theuser answered “Yes”. If the user answer is “No”, at 1034, the user isnotified that the specified rate is greater than the formulary maximum.Additionally, the user is asked to verify again that the specified rateshould be used. At 1036, the user answer to this prompt is processed. Ifthe user answer is “Yes”, at 1032, the new rate is displayed. If theuser answer is “No”, at 1038, the rate field is cleared.

In an example embodiment, a drug delivery safety system includes aprogrammer with a display and a communications device adapted tocommunicate with an ambulatory medical device. The programmer has accessto a database of information, and is adapted to receive and process theinformation and a user input and to control the display to provide agraphical user interface that prompts a user of the programmer toprovide an additional user input when the user input requests a drugdelivery protocol for the ambulatory medical device that is not alreadystored in the database as a clinician-approved drug delivery protocol.By way of example, the ambulatory medical device can be an implantablemedical device or implantable drug pump. In an example embodiment, theinformation is clinic-specific and/or patient-specific.

In an example embodiment, the programmer is adapted to deny a requesteddrug delivery protocol that is not clinician-approved. In an exampleembodiment, the programmer is adapted to limit a requested drug deliveryprotocol, that is not clinician-approved, to conform with theclinician-approved drug delivery protocol.

In an example embodiment, the programmer is adapted to control thegraphical user interface to prompt the user for a verification of arequested change to the drug delivery protocol. By way of example, therequested change can be one or more of: a therapeutic change, aconcentration change, and a rate change.

In an example embodiment, the programmer is adapted to control thegraphical user interface to prompt the user for a verification of arequest to add a new drug delivery protocol to the database. In anexample embodiment, the new drug delivery protocol is for a new drugthat is not already associated with any clinician-approved drug deliveryprotocol stored in the database.

In an example embodiment, the programmer is adapted to control thegraphical user interface to generate a warning to the user that therequested change to the drug delivery protocol is notclinician-approved. In an example embodiment, the warning is generatedwhen the requested change exceeds a permitted change to a dosage for aparticular drug. By way of example, the dosage is a daily dosage or aPatient Controlled Analgesia (PCA) dosage. By way of example, thepermitted change is a (fixed) percentage increase or decrease (e.g.,20%). In an example embodiment, the warning is generated when therequested change exceeds a maximum rate limit for a particular drug. Byway of example, the maximum rate limit can be either of maximum basalrate, a maximum temporary rate, or a maximum Patient ControlledAnalgesia (PCA) bolus rate. The maximum temporary rate is a rate thatdisplaces the maximum basil rate (e.g., during a particular timeinterval each day). In an example embodiment, the warning prompts theuser to indicate whether the user wishes to override the warning. In anexample embodiment, the warning prompts the user to indicate whether theuser wishes to modify the clinician-approved drug delivery protocol. Inan example embodiment, the warning prompts the user to indicate whetherthe user wishes to create a new drug delivery protocol.

In an example embodiment, the programmer is adapted to control thegraphical user interface to generate a confirmation window relating todata that is to be written to the ambulatory medical device. In anexample embodiment, the confirmation window displays both previous andnew values for the drug delivery protocol. In an example embodiment, theconfirmation window displays programming changes as highlighted. In anexample embodiment, the confirmation window prompts the user to indicatewhether the user wishes to accept programming changes before data iswritten to the ambulatory medical device.

Referring to FIG. 7, in an example embodiment, a method 700 ofcontrolling a drug delivery safety system is now described. At 702,implantable drug pump (IDP) information and a request to change a drugdelivery protocol currently associated with the IDP are received andprocessed (e.g., by the controller 138). At 704, the display 148 iscontrolled to provide/update an indication of an estimated date when theIDP will experience a low reservoir condition. At 706, a determinationis made as to whether a user has input a parameter (e.g., daily dosagevolume) associated with the drug delivery profile. If “Yes”, thecontroller processes the parameter and updates the indication of anestimated date when the IDP will experience a low reservoir condition.If “No”, the processor monitors for new requests to change a drugdelivery protocol currently associated with the IDP.

Referring again to FIG. 11, in this example embodiment, the graphicaluser interface 1100 includes a Reservoir Volume display area 1120, whichdisplays a calculation of an empty reservoir date in response to a dailydosage change. Referring also to FIG. 18, in this example embodiment,the Reservoir Volume display area 1120 includes an empty reservoir dateindication field 1122 which is updated by the controller 138 when a newvalue is entered into the daily dosage field 1124. In an exampleembodiment, the empty reservoir date is calculated based on the IDP'scurrent delivery regime and any ongoing delivery procedures. In anexample embodiment, the programmer 100 a is configured such that thealarm 147 is activated on the empty reservoir date calculated. In thisexample embodiment, the Reservoir Volume display area 1120 includes abutton 1126 which can be actuated by a user of the programmer 100 a torequest a standard refill for the implantable drug pump.

In an example embodiment, a drug delivery safety system includes aprogrammer with a display and a communications device adapted tocommunicate with an implantable drug pump. The programmer has access toa database of information relating to the implantable drug pump, and isadapted to receive and process the information and a user input relatingto a requested change to a drug delivery protocol currently associatedwith the implantable drug pump, and to control the display to provide anindication of an estimated date in which the implantable drug pump willexperience a low reservoir condition. By way of example, the requestedchange is to a daily dosage.

In an example embodiment, the programmer is adapted to control thedisplay to generate a graphical user interface. In an exampleembodiment, the graphical user interface includes a field in which theindication of an estimated date is presented. In an example embodiment,the graphical user interface provides a graphical indication (e.g., agage) of a reservoir volume for the implantable drug pump. In an exampleembodiment, the graphical user interface allows a user of the programmerto input a parameter associated with the drug delivery protocol. In anexample embodiment, the programmer controls the graphical user interfaceto automatically update the indication of an estimated date dependingupon the parameter. In an example embodiment, the parameter specifies adaily dosage volume. In an example embodiment, the graphical userinterface includes a button which can be actuated by a user of theprogrammer to request a standard refill for the implantable drug pump.

Although the inventions disclosed herein have been described in terms ofthe preferred embodiments above, numerous modifications and/or additionsto the above-described preferred embodiments would be readily apparentto one skilled in the art. The inventions also include any combinationof the elements from the various species and embodiments disclosed inthe specification that are not already described. It is intended thatthe scope of the present inventions extend to all such modificationsand/or additions and that the scope of the present inventions is limitedsolely by the claims set forth below.

1. A drug delivery safety system, comprising: a programmer including adisplay and a communications device adapted to communicate with anambulatory medical device, the programmer having access to a database ofinformation, the programmer being adapted to receive and process theinformation and a user input and to control the display to provide agraphical user interface that prompts a user of the programmer toprovide an additional user input when the user input requests a drugdelivery protocol for the ambulatory medical device that is not alreadystored in the database as a clinician-approved drug delivery protocol.2. The drug delivery safety system of claim 1, wherein the ambulatorymedical device is an implantable medical device.
 3. The drug deliverysafety system of claim 1, wherein the ambulatory medical device is animplantable drug pump.
 4. The drug delivery safety system of claim 1,wherein the information is clinic-specific.
 5. The drug delivery safetysystem of claim 1, wherein the information is patient-specific.
 6. Thedrug delivery safety system of claim 1, wherein the programmer isadapted to deny a requested drug delivery protocol that is notclinician-approved.
 7. The drug delivery safety system of claim 1,wherein the programmer is adapted to limit a requested drug deliveryprotocol that is not clinician-approved to conform with theclinician-approved drug delivery protocol.
 8. The drug delivery safetysystem of claim 1, wherein the programmer is adapted to control thegraphical user interface to prompt the user for a verification of arequested change to the drug delivery protocol.
 9. The drug deliverysafety system of claim 8, wherein the requested change is a therapeuticchange.
 10. The drug delivery safety system of claim 8, wherein therequested change is a concentration change.
 11. The drug delivery safetysystem of claim 8, wherein the requested change is a rate change. 12.The drug delivery safety system of claim 1, wherein the programmer isadapted to control the graphical user interface to prompt the user for averification of a request to add a new drug delivery protocol to thedatabase.
 13. The drug delivery safety system of claim 12, wherein thenew drug delivery protocol is for a new drug that is not alreadyassociated with any clinician-approved drug delivery protocol stored inthe database.
 14. The drug delivery safety system of claim 1, whereinthe programmer is adapted to control the graphical user interface togenerate a warning to the user that the requested change to the drugdelivery protocol is not clinician-approved.
 15. The drug deliverysafety system of claim 14, wherein the warning is generated when therequested change exceeds a permitted change to a dosage for a particulardrug.
 16. The drug delivery safety system of claim 15, wherein thedosage is a daily dosage.
 17. The drug delivery safety system of claim15, wherein the dosage is a Patient Controlled Analgesia (PCA) dosage.18. The drug delivery safety system of claim 15, wherein the permittedchange is a fixed percentage increase.
 19. The drug delivery safetysystem of claim 15, wherein the permitted change is a fixed percentagedecrease.
 20. The drug delivery safety system of claim 15, wherein thepermitted change is approximately 20%.
 21. The drug delivery safetysystem of claim 14, wherein the warning is generated when the requestedchange exceeds a maximum rate limit for a particular drug.
 22. The drugdelivery safety system of claim 21, wherein the maximum rate limit is amaximum basal rate.
 23. The drug delivery safety system of claim 21,wherein the maximum rate limit is a maximum temporary rate.
 24. The drugdelivery safety system of claim 21, wherein the maximum rate limit is amaximum Patient Controlled Analgesia (PCA) bolus rate.
 25. The drugdelivery safety system of claim 14, wherein the warning prompts the userto indicate whether the user wishes to override the warning.
 26. Thedrug delivery safety system of claim 14, wherein the warning prompts theuser to indicate whether the user wishes to modify theclinician-approved drug delivery protocol.
 27. The drug delivery safetysystem of claim 14, wherein the warning prompts the user to indicatewhether the user wishes to create a new drug delivery protocol.
 28. Thedrug delivery safety system of claim 1, wherein the programmer isadapted to control the graphical user interface to generate aconfirmation window relating to data that is to be written to theambulatory medical device.
 29. The drug delivery safety system of claim28, wherein the confirmation window displays both previous and newvalues for the drug delivery protocol.
 30. The drug delivery safetysystem of claim 28, wherein the confirmation window displays programmingchanges as highlighted.
 31. The drug delivery safety system of claim 28,wherein the confirmation window prompts the user to indicate whether theuser wishes to accept programming changes before data is written to theambulatory medical device.
 32. A drug delivery safety system,comprising: a programmer including a display and a communications deviceadapted to communicate with an implantable drug pump, the programmerhaving access to a database of therapeutic limits information relatingto the implantable drug pump, the programmer being adapted to receiveand process the therapeutic limits information and a user input relatingto a requested change to a drug delivery protocol currently associatedwith the implantable drug pump, and to control the display to provide anindication of an estimated date in which the implantable drug pump willexperience a low reservoir condition.
 33. The drug delivery safetysystem of claim 32, wherein the requested change is to a daily dosage.34. The drug delivery safety system of claim 32, wherein the programmeris adapted to control the display to generate a graphical userinterface.
 35. The drug delivery safety system of claim 34, wherein thegraphical user interface includes a field in which the indication of anestimated date is presented.
 36. The drug delivery safety system ofclaim 34, wherein the graphical user interface provides a graphicalindication of a reservoir volume for the implantable drug pump.
 37. Thedrug delivery safety system of claim 36, wherein the graphicalindication is a gage.
 38. The drug delivery safety system of claim 34,wherein the graphical user interface allows a user of the programmer toinput a parameter associated with the drug delivery protocol.
 39. Thedrug delivery safety system of claim 38, wherein the programmer controlsthe graphical user interface to automatically update the indication ofan estimated date depending upon the parameter.
 40. The drug deliverysafety system of claim 38, wherein the parameter specifies a dailydosage volume.
 41. The drug delivery safety system of claim 34, whereinthe graphical user interface includes a button which can be actuated bya user of the programmer to request a standard refill for theimplantable drug pump.